The present invention relates to medical lubricants such as gloving powders and mold release agents and, more particularly, to the use of oxidized cellulose in these capacities.
Post-operative complications such as adhesions, peritonitis, and granuloma formation have been attributed to the use of non-absorbable lubricants on surgical gloves and other surgical elements. Talc powders, for years, were used as dusting powders for surgical gloves until it was found that they caused severe foreign body reactions in patients. As a result, talc powders were replaced by bioabsorbable starch powders of the type disclosed in U.S. Pat. No. 2,626,257 to Caldwell et al (1953). Even starch particles, however, have been implicated in the production of granulomatus lesions. Some researchers attribute starch granuloma to the presence of talc and other non-absorbable inorganics in the starch, whereas other researchers believe that in some cases the starches are so highly cross-linked that they cannot be sufficiently absorbed by the body tissue. As a result, there is a need for a medical lubricant which is more readily absorbable and free from or accompanied by less severe foreign body reactions.
Efforts directed to providing an absorbable, granuloma-free medical lubricant have provided the following materials:
U.S. Pat. No. 2,864,743 to Kestler et al (1958): a modified starch particle obtained by condensing a magnesium or aluminum salt with epichlorohydrin etherified starch.
U.S. Pat. No. 2,938,901 to Kerr et al (1960): starch esterified in its unswollen granule state by reaction with a water soluble metaphosphate salt.
U.S. Pat. No. 3,122,482 to Smith (1964): calcium salts of phosphated or sulfated starches.
U.S. Pat. No. 3,133,866 to Richardson (1964): inorganic powders such as talc in admixture with an acid salt of the polybasic phosphoric acid.
U.S. Pat. No. 3,728,739 to Semp (1973): finely divided polyglycolic acid.
U.S. Pat. No. 4,053,3769 to Fox et al (1977): etherified starch treated with an acid or alkaline medium and heated until is exhibits a predetermined reducing power.
U.S. Pat. No. 4,064,564 to Casey (1977): enzymatically degradable forms of poly(N-acetyl-D-glucosamine).
U.S. Pat. No. 4,143,423 to Sternlieb (1979): sodium and potassium salts such as sodium or potassium carbonate, bicarbonate, acetate, acetate trihydrate, and citrate dihydrate.
U.S. Pat. No. 4,152,783 to Choski (1979): water soluble inocuous powders such as sodium bicarbonate.
U.S. Pat. No. 4,310,928 to Joung (1982): lipids and lipophilic compounds such as fatty acids, fatty acid esters and lipophilic particles and an associated surfactant added to a coagulant bath as a mold release agent.
Oxidized cellulosse has been found useful in various medical/surgical applications in the past, but its use as a donning powder or medical lubricant has not been suggested. For example, V. Frantz, "New Absorbable Hemostatic Agents", Bull N.Y. Acad. Med., 22: 102,1946 showed that is could be used as a carrier for thrombin and had useful hemostatic properties of its own. Cellulose partially oxidized by periodate has also been studied in the immobilization of trypsin (Biotech. and Bioeng, 16: 997-1003, 1974) and chyrotrypsin (Singh et al, "Potential Biosoluble Carriers: Biocompatibility and Biodegradability of Oxidized Cellulose", Biomat., Med. Dev., Art. Orig., 7(4), 495-512 (1979)), and it has been tested for implantation in body tissues to prevent adhesions.